Sun Pharma Advanced Research Company Limited (SPARC), part of Sun Pharmaceutical Industries, has received a Complete Response Letter (CRL) from the US Food and Drug Administration (FDA) regarding manufacturing issues at Sun Pharma’s Halo, India manufacturing site. 

The CRL relates to a new drug application for Elepsia XR (levetiracetam extended-release tablets 1000 mg and 1500 mg), an anti-epileptic drug. The CRL references the recent inspection of the Halol manufacturing site by the FDA and indicates that the satisfactory resolution of the deficiencies identified during the inspection is required before the final approval of Elepsia XR can be granted. The announcement of the CRL was by SPARC in a filing to the National Stock Exchange of India. 

SPARC had out-licensed Elepsia XR to a subsidiary of Sun Pharmaceutical Industries in July 2016. In the announcement, SPARC says that Sun Pharma is working with the FDA for resolving the cGMP deviations at the Halol facility and has taken several corrective measures.

Elepsia XR was approved by the FDA in March 2015, but SPARC received a letter from the FDA in September 2015 rescinding the earlier approval because the compliance status of the manufacturing facility at Sun Pharma’s Halol, India site was not cGMP compliant at the time of approval. Sun Pharma has since then undertaken remediation at the Halol site for restoring cGMP-compliance status. The issuance of the CRL indicates that satisfactory resolution of those deficiencies are still ongoing.

The in-licensing of Elepsia XR is expected to facilitate Sun Pharma’s entry into the central nervous system market segment in the US. Levetiracetam products currently approved by the FDA and available on the US market are generally indicated for adjunctive therapy in the treatment of partial onset seizures in patients 12 years of age and older with epilepsy.

Source: SPARC